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https://www.readbyqxmd.com/read/29908359/statin-therapy-does-not-reduce-liver-fat-scores-in-patients-receiving-antiretroviral-therapy-for-hiv-infection
#1
Vanessa El Kamari, Corrilynn O Hileman, Pierre M Gholam, Manjusha Kulkarni, Nicholas Funderburg, Grace A McComsey
BACKGROUND & AIMS: Therapies are needed to limit progression of fatty liver diseases in patients with HIV infection. We analyzed data from a prospective study of the effects of rosuvastatin (a statin) on hepatic steatosis in HIV-positive adults. METHODS: We performed secondary analysis of data from a double-blind trial of adult patients with HIV infection (78% male; 68% African American; mean age, 46 years; body mass index, 29 kg/m2 ; HIV1 RNA<1000 copies/mL; LDL-cholesterol <130 mg/dL) receiving antiretroviral therapy...
June 13, 2018: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29908297/prevention-of-breast-cancer-treatment-induced-bone-loss-in-premenopausal-women-treated-with-zoledronic-acid-final-5-year-results-from-the-randomized-double-blind-placebo-controlled-probone-ii-trial
#2
Ioannis Kyvernitakis, Peter Herbert Kann, Friederike Thomasius, Olaf Hars, Peyman Hadji
PURPOSE: Premenopausal women receiving chemotherapy or endocrine treatment for early breast cancer are at increased risk for cancer treatment induced bone loss (CTIBL). The aim of the randomized, double-blind ProBONE II trial was to investigate whether a 2-year adjuvant treatment with 4 mg intravenous zoledronic acid (ZOL) every 3 months versus placebo would prevent CTIBL after a five-year period. METHODS: Thirty-one of the 34 participants in the ZOL arm and thirty-four of the 36 participants in the placebo arm were followed-up to the 5-year visit and completed the study as planned...
June 13, 2018: Bone
https://www.readbyqxmd.com/read/29908043/a-first-in-human-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-pf-06741086-an-anti-tfpi-monoclonal-antibody-in-healthy-volunteers
#3
Matthew Cardinal, Constantino Kantaridis, Tong Zhu, Pengling Sun, Debra D Pittman, John E Murphy, Steven Arkin
BACKGROUND: Tissue factor pathway inhibitor (TFPI) is a protease inhibitor of tissue factor-activated coagulation factor VII (TF-FVIIa) complex and activated factor X (FXa). PF-06741086 is a monoclonal antibody that targets TFPI to increase clotting activity. OBJECTIVES: This study was a randomized, double-blind, sponsor-open, placebo-controlled, single intravenous (IV) or subcutaneous (SC) dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06741086...
June 16, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29908038/the-effect-of-dietary-corn-oil-and-fish-oil-supplementation-in-dogs-with-naturally-occurring-gingivitis
#4
Ana L Lourenço, Henriette E Booij-Vrieling, Carmen B Vossebeld, António Neves, Carlos Viegas, Ronald J Corbee
The aim of this randomized, double-blinded, placebo-controlled study was to evaluate if downregulation of the inflammatory response due to ingestion of high levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) can slow down gingivitis development, and thus delay the progression of periodontal disease (PD) in dogs. To this aim, 44 client-owned adult dogs (>1 and <8 years old) with naturally occurring PD (stages 1 and 2) were submitted to a plaque, gingivitis and calculus scoring followed by a dental cleaning procedure and collection of blood samples...
June 16, 2018: Journal of Animal Physiology and Animal Nutrition
https://www.readbyqxmd.com/read/29907608/noninvasive-vagus-nerve-stimulation-as-acute-therapy-for-migraine-the-randomized-presto-study
#5
Cristina Tassorelli, Licia Grazzi, Marina de Tommaso, Giulia Pierangeli, Paolo Martelletti, Innocenzo Rainero, Stefanie Dorlas, Pierangelo Geppetti, Anna Ambrosini, Paola Sarchielli, Eric Liebler, Piero Barbanti
OBJECTIVE: To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial. METHODS: A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes...
June 15, 2018: Neurology
https://www.readbyqxmd.com/read/29907124/exon-skipping-for-duchenne-muscular-dystrophy-a-systematic-review-and-meta-analysis
#6
Yuko Shimizu-Motohashi, Terumi Murakami, En Kimura, Hirofumi Komaki, Norio Watanabe
BACKGROUND: Exon skipping has been considered a promising therapeutic approach for Duchenne muscular dystrophy (DMD). Eteplirsen received conditional approval in the United States in 2016. To date, no systematic reviews or meta-analyses of randomized controlled trials (RCTs) of exon skipping drugs have been published to determine the pooled estimates for the effect of exon skipping in treating DMD. METHODS: A systematic review and meta-analysis of double-blind RCTs comparing exon-skipping drugs with placebo in DMD was performed...
June 15, 2018: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/29907111/changes-in-biomarkers-in-equine-synovial-fluid-two-weeks-after-intra-articular-hyaluronan-treatment-a-randomised-double-blind-clinical-trial
#7
Tytti M Niemelä, Riitta-Mari Tulamo, Kaisa Aaltonen, Satu M Sankari, Anna K Hielm-Björkman
BACKGROUND: Inflammatory and degenerative activity inside the joint can be studied in vivo via analysis of synovial fluid (SF) biomarkers, which are molecular markers of inflammatory processes and tissue turnover. The aim of this study was to investigate the response of selected biomarkers in the SF after an intra-articular (IA) high-molecular-weight non-animal stabilized hyaluronic acid (NASHA) treatment. Our hypothesis was that prostaglandin E2 (PGE2 ), substance P, aggrecan chondroitin sulfate 846 epitope (CS846), and carboxypeptide of type II collagen (CPII) concentrations in SF would decrease more in the NASHA than in the placebo group...
June 15, 2018: BMC Veterinary Research
https://www.readbyqxmd.com/read/29906709/short-term-efficacy-and-tolerability-of-lurasidone-in-the-treatment-of-acute-schizophrenia-a-meta-analysis-of-randomized-controlled-trials
#8
REVIEW
Wei Zheng, Dong-Bin Cai, Xin-Hu Yang, Lu Li, Qing-E Zhang, Chee H Ng, Gabor S Ungvari, Xian-Bin Li, Yu-Ping Ning, Yu-Tao Xiang
BACKGROUND: Lurasidone, an azapirone derivative, is a novel second generation antipsychotic with potent binding affinity for dopamine D2, serotonin 5-HT2A , 5-HT7, 5-HT1A, and noradrenaline alpha2C receptors. This updated meta-analysis of randomized controlled trials (RCTs) examined the short-term efficacy and tolerability of lurasidone in the treatment of acute schizophrenia. METHODS: Double-blinded RCTs reporting on the short-term effects of lurasidone were included...
June 5, 2018: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/29906642/the-effect-of-simethicone-on-postoperative-ileus-in-patients-undergoing-colorectal-surgery-spot-a-randomized-controlled-trial
#9
Jeremy E Springer, Shiraz Elkheir, Cagla Eskicioglu, Aristithes G Doumouras, Stephen Kelly, Ilun Yang, Shawn Forbes
BACKGROUND: Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. OBJECTIVE: This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery...
June 12, 2018: International Journal of Surgery
https://www.readbyqxmd.com/read/29906570/randomized-placebo-controlled-phase-iii-trial-of-fosaprepitant-ondansetron-dexamethasone-fond-versus-fond-plus-olanzapine-fond-o-for-the-prevention-of-chemotherapy-induced-nausea-and-vomiting-in-patients-with-hematologic-malignancies-receiving-highly-emetogenic
#10
Amber B Clemmons, Julianne Orr, Benjamin Andrick, Arpita Gandhi, Claude Sportes, David DeRemer
Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy (HEC); however, most studies focus on solid malignancies and single day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone; FOND-O) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single and multi-day HEC and hematopoietic cell transplant (HCT) regimens (NCT02635984)...
June 12, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29906251/randomized-double-blind-phase-ii-study-of-temozolomide-in-combination-with-either-veliparib-or-placebo-in-patients-with-relapsed-sensitive-or-refractory-small-cell-lung-cancer
#11
M Catherine Pietanza, Saiama N Waqar, Lee M Krug, Afshin Dowlati, Christine L Hann, Alberto Chiappori, Taofeek K Owonikoko, Kaitlin M Woo, Robert J Cardnell, Junya Fujimoto, Lihong Long, Lixia Diao, Jing Wang, Yevgeniva Bensman, Brenda Hurtado, Patricia de Groot, Erik P Sulman, Ignacio I Wistuba, Alice Chen, Martin Fleisher, John V Heymach, Mark G Kris, Charles M Rudin, Lauren Averett Byers
Purpose Both temozolomide (TMZ) and poly (ADP-ribose) polymerase (PARP) inhibitors are active in small-cell lung cancer (SCLC). This phase II, randomized, double-blind study evaluated whether addition of the PARP inhibitor veliparib to TMZ improves 4-month progression-free survival (PFS). Patients and Methods A total of 104 patients with recurrent SCLC were randomly assigned 1:1 to oral veliparib or placebo 40 mg twice daily, days 1 to 7, and oral TMZ 150 to 200 mg/m2 /day, days 1 to 5, of a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent...
June 15, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29905977/inspiromatic-safety-and-efficacy-study-of-a-new-generation-dry-powder-inhaler-in-asthmatic-children
#12
Guy Steuer, Dario Prais, Huda Mussaffi, Meir Mei-Zahav, Ophir Bar-On, Hagit Levine, Yulia Gendler, Hannah Blau, Patrick Stafler
BACKGROUND: Dry powder inhalers (DPI) are effective but forceful inhalation required to fluidize the powder may be difficult for children and patients with airway disease. Inspiromatic is a new generation active DPI that actively suspends drugs in synchrony with inhalation. We evaluated safety and efficacy of Formoterol delivery via Inspiromatic, compared to Aerolizer, a conventional DPI, in pediatric asthmatic subjects. METHODS: A phase I/II, randomized, single-center, double-blind, double-dummy, placebo-controlled, cross-over study...
June 15, 2018: Pediatric Pulmonology
https://www.readbyqxmd.com/read/29905927/multicenter-randomized-double-blind-phase-2-trial-of-folfiri-with-regorafenib-or-placebo-as-second-line-therapy-for-metastatic-colorectal-cancer
#13
Hanna K Sanoff, Richard M Goldberg, Anastasia Ivanova, Seamus O'Reilly, Samer S Kasbari, Richard D Kim, Ray McDermott, Dominic T Moore, William Zamboni, William Grogan, Allen Lee Cohn, Tanios S Bekaii-Saab, Gregory Leonard, Theresa Ryan, Olugbenga O Olowokure, Nishan H Fernando, John McCaffrey, Bassel F El-Rayes, Anne M Horgan, Gary Bradley Sherrill, George Hosni Yacoub, Bert H O'Neil
BACKGROUND: Regorafenib, a multikinase inhibitor that inhibits angiogenesis, growth, and proliferation, prolongs survival as monotherapy in patients with refractory colorectal cancer. This international, double-blind, placebo-controlled, multicenter trial assessed the efficacy of regorafenib with folinic acid, fluorouracil, and irinotecan (FOLFIRI) as a second-line treatment for metastatic colorectal cancer. METHODS: Patients with metastatic colorectal cancer who progressed on first-line oxaliplatin and fluoropyrimidine enrolled at 45 sites in the United States and Ireland...
June 15, 2018: Cancer
https://www.readbyqxmd.com/read/29905824/milk-powder-added-to-a-school-meal-increases-cognitive-test-scores-in-ghanaian-children
#14
Reginald Lee, Lauren Singh, Danielle van Liefde, Meghan Callaghan-Gillespie, Matilda Steiner-Asiedu, Kwesi Saalia, Carly Edwards, Anja Serena, Tamara Hershey, Mark J Manary
Background: The inclusion of milk in school feeding is accepted as good nutritional practice, but specific benefits remain uncertain. Objective: The objective was to determine whether consumption of 8.8 g milk protein/d given as milk powder with a multiple micronutrient-enriched porridge resulted in greater increases in linear growth and Cambridge Neuropsychological Test Automated Battery (CANTAB) scores in Ghanaian schoolchildren when compared with 1 of 3 control groups...
June 14, 2018: Journal of Nutrition
https://www.readbyqxmd.com/read/29905383/guselkumab-an-anti-interleukin-23-monoclonal-antibody-for-the-treatment-of-moderate-to-severe-plaque-type-psoriasis-in-japanese-patients-efficacy-and-safety-results-from-a-phase-3-randomized-double-blind-placebo-controlled-study
#15
Mamitaro Ohtsuki, Hiroshi Kubo, Hitomi Morishima, Ryosuke Goto, Richuan Zheng, Hidemi Nakagawa
Previous global studies of guselkumab have demonstrated clinical benefits in patients with psoriasis. The aim of this 52-week, phase 3 study was to evaluate efficacy and safety of guselkumab in Japanese patients with moderate to severe plaque-type psoriasis. Patients randomly received guselkumab 50 mg or 100 mg at weeks 0, 4 and every 8 weeks, or placebo with cross-over to guselkumab 50 mg or 100 mg at week 16. Co-primary end-points were the proportion of patients achieving Investigator's Global Assessment (IGA) cleared/minimal (0/1) and 90% or more improvement in Psoriasis Area and Severity Index (PASI-90) at week 16...
June 15, 2018: Journal of Dermatology
https://www.readbyqxmd.com/read/29904968/safety-and-efficacy-of-topical-cantharidin-for-the-treatment-of-pediatric-molluscum-contagiosum-a-prospective-randomized-double-blind-placebo-controlled-pilot-trial
#16
Anthony K Guzman, David O Schairer, Jessica L Garelik, Steven R Cohen
Topical cantharidin is a commonly used treatment for molluscum contagiosum (MC). However, studies validating its safety and efficacy are limited. We conducted a 6-week, randomized, double-blind, placebo-controlled trial with subsequent open-label extension to assess the safety and effectiveness of cantharidin in treating pediatric MC. Ninety-four participants with MC were randomized to receive cantharidin or placebo, with or without occlusion. The primary outcome was complete lesion clearance. Secondary outcomes included post-treatment lesion count, adverse events, and side effects...
June 15, 2018: International Journal of Dermatology
https://www.readbyqxmd.com/read/29904617/comparing-the-harmonic-scalpel-with-electrocautery-in-reducing-postoperative-flap-necrosis-and-seroma-formation-after-modified-radical-mastectomy-in-carcinoma-breast-patients-a-double-blind-prospective-randomized-control-trail
#17
Arumugom Archana, Sathasivam Sureshkumar, Chellappa Vijayakumar, Chinnakali Palanivel
Introduction Only a few studies compare the efficacy of the harmonic scalpel and electrocautery in performing mastectomies, and these have mainly compared their intraoperative parameters. But the main concern with electrocautery is the incidence of flap necrosis and seroma formation. Therefore, this study was done to determine if the harmonic scalpel has any advantages over electrocautery in reducing postoperative flap necrosis and seroma formation in patients undergoing a modified radical mastectomy (MRM)...
April 13, 2018: Curēus
https://www.readbyqxmd.com/read/29903473/growth-stool-consistency-and-bone-mineral-content-in-healthy-term-infants-fed-sn-2-palmitate-enriched-starter-infant-formula-a-randomized-double-blind-multicentre-clinical-trial
#18
Laurent Béghin, Xavier Marchandise, Eric Lien, Myriam Bricout, Jean-Paul Bernet, Jean-François Lienhardt, Françoise Jeannerot, Vincent Menet, Jean-Christophe Requillart, Jacques Marx, Nanda De Groot, Jonathan Jaeger, Philippe Steenhout, Dominique Turck
BACKGROUND: Palmitate in breast milk is predominantly located in the triacylglycerol sn-2 position, while infant formulae contain palmitate predominantly in the sn-1 and sn-3 positions. During digestion, palmitate in the sn-1 and sn-3 positions is hydrolyzed to free palmitic acid that can subsequently complex with calcium to form insoluble soaps; this may partially explain why formula-fed infants have harder stools than breast-fed infants. METHODS: This large (n = 488) randomized, double-blind, multicentre trial investigated whether increasing the sn-2 palmitate content of infant formula improves stool consistency and bone mineral content (measured by dual-energy x-ray absorptiometry), without affecting growth or health...
June 1, 2018: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/29903459/single-injection-adductor-canal-block-with-multiple-adjuvants-provides-equivalent-analgesia-when-compared-with-continuous-adductor-canal-blockade-for-primary-total-knee-arthroplasty-a-double-blinded-randomized-controlled-equivalency-trial
#19
James D Turner, Sean W Dobson, Daryl S Henshaw, Christopher J Edwards, Robert S Weller, Jon W Reynolds, Gregory B Russell, Jonathan D Jaffe
BACKGROUND: Peripheral nerve blockade is used to provide analgesia for patients undergoing total knee arthroplasty. This study compared a single-injection adductor canal block (SACB) with adjuvants to continuous adductor canal blockade (CACB). The hypothesis was that the 2 groups would have equivalent analgesia at 30 hours after neural blockade. METHODS: This was a double-blinded, randomized, controlled, equivalency trial. Sixty patients were randomized to either the SACB group (20 mL of 0...
May 24, 2018: Journal of Arthroplasty
https://www.readbyqxmd.com/read/29903051/rapid-antidepressant-effects-of-the-psychedelic-ayahuasca-in-treatment-resistant-depression-a-randomized-placebo-controlled-trial
#20
Fernanda Palhano-Fontes, Dayanna Barreto, Heloisa Onias, Katia C Andrade, Morgana M Novaes, Jessica A Pessoa, Sergio A Mota-Rolim, Flávia L Osório, Rafael Sanches, Rafael G Dos Santos, Luís Fernando Tófoli, Gabriela de Oliveira Silveira, Mauricio Yonamine, Jordi Riba, Francisco R Santos, Antonio A Silva-Junior, João C Alchieri, Nicole L Galvão-Coelho, Bruno Lobão-Soares, Jaime E C Hallak, Emerson Arcoverde, João P Maia-de-Oliveira, Dráulio B Araújo
BACKGROUND: Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression. METHODS: To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing...
June 15, 2018: Psychological Medicine
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